Search Results

Nobel Biocare Endosseous Implants are indicated for maxillofacial use. They are intended to be used as the foundation for anchoring prosthesis or epithesis in the craniofacial region.

This submission extends the indication for the Nobel Biocare Endosseous Implants to use in maxillofacial reconstructive surgery. There is no change to existing product marketed for dental applications.

The provided text is a 510(k) summary and related correspondence for the Nobel Biocare Endosseous Implants for Maxillofacial Indication. This document does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is focused on extending an existing indication.

Therefore, I cannot provide the requested information from the given text.

The document indicates that the device is substantially equivalent to legally marketed predicate devices, meaning it does not require new performance studies to demonstrate safety and effectiveness for the extended indication. Instead, the focus is on the device description and its intended use.

Ask a specific question about this device

Nobel Biocare Endosseous Implants are indicated for use as root form endosseous implants in partially or fully edentulous patients for the purpose of restoring chewing function. Implants may be tilted up to 45°. When used with angulations between 30° and 45°, the following applies:

• the tilted implants must be splinted
• a minium of four implants must be used when supporting a fixed prosthesis in a fully edentulous arch

Nobel Biocare Endosseous Implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore chewing function to partially or fully edentulous patients.

Nobel Biocare Endosseous Implants are machined from titanium and available straight or tapered. The implants are either a) coated with hydroxyapatite powder, i.e. HA coated implants; b) have a surface treatment of the implant that consists of a titanium oxide layer, i.e. TiUnite implants; or c) do not have any coating or surface treatment, i.e. Branemark implants.

Nobel Biocare Endosseous Implants may be placed in the oral cavity using either a single stage surgical procedure or a two stage surgical procedure. If a single stage procedure is used, the implants may be immediately loaded following insertion. Nobel Biocare Endosseous Implants can be placed anywhere in the upper or lower jaw where good initial stability of the implant can be obtained.

This document is a 510(k) summary for Nobel Biocare Endosseous Implants. It does not contain any information regarding acceptance criteria or a study proving that the device meets acceptance criteria.

The 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It typically focuses on comparing the new device's design, materials, and intended use to an existing predicate device, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot extract the requested information (points 1-9) from this document.

Ask a specific question about this device

The MDI and MDI PLUS are self-tapping titanium threaded screws indicated for long-term intra-bony applications. Additionally, the MDI may also be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full partial endentulism, and employing minimally invasive surgical intervention.

self-tapping titanium threaded screws

The provided text is a 510(k) premarket notification letter from the FDA regarding the "IMTEC Sendax MDI and MDI PLUS" dental implants. This document does not contain information about acceptance criteria, study methodologies, or performance metrics for an AI/CADe device.

Therefore, I cannot provide the requested information. The text is a regulatory clearance document, not a scientific study report.

Ask a specific question about this device

The Nobel Biocare Replace TiUnite Endosseous Implant is intended to be placed in the upper or lower jaw to support prosthetic devices such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure.

If the single stage procedure is used, these implants may be loaded immediately following insertion -- provided -- at least four implants are placed, and are splinted with a bar. These implants must be placed predominantly in the anterior mandible (between the mental foramina) where good initial stability of the implants, with or without bi-cortical anchorage, can most often be obtained.

The Replace TiUnite endosseous implant is a threaded root-form dental implant. It comes in widths of 3.5mm, 4.3mm, 5.0mm, and 6.0mm. Each width comes in lengths of 10mm, 13mm, and 16mm. The surface of the threaded portion of the implant has a titanium oxide layer that is uniformly thin (mean

This document is a 510(k) summary for the Replace TiUnite Endosseous Implant, an endosseous dental implant. It primarily focuses on the regulatory submission and does NOT contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The provided text details the device description, indications for use, and a letter from the FDA confirming substantial equivalence to a predicate device, which is part of the regulatory approval process but does not include clinical study data or performance metrics.

Ask a specific question about this device

The Brånemark Integration AB, FIXTURE ORIGINAL is intended for surgical placement into the bone of upper /lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function.

The FIXTURE ORIGINAL consists of 4 implants, diameter 3,75 mm, and length from 8,5 to 15 mm.

The provided text describes a 510(k) submission for the "FIXTURE ORIGINAL" endosseous implant. However, it does not include detailed acceptance criteria or a study that directly proves the device meets specific acceptance criteria in the way typically expected for performance-based medical device submissions.

Instead, this submission primarily relies on substantial equivalence to a predicate device (Nobel Biocare AB standard fixture RP with a diameter of 3.75 mm). The core argument is that because the FIXTURE ORIGINAL is similar in material, dimensions, and intended use to the predicate device, further testing "will not raise new issues of safety and efficacy."

Therefore, many of the requested sections below cannot be fully populated as the information is not present in the provided document.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

• Explanation: The document does not define specific performance acceptance criteria (e.g., minimum tensile strength, fatigue life, osseointegration rates, etc.) for the FIXTURE ORIGINAL itself, nor does it present specific performance data against such criteria. The entire premise of the submission is that the device's characteristics are so similar to a legally marketed predicate that specific new performance testing is deemed unnecessary.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable / Not provided. The submission relies on substantial equivalence and does not describe a new performance test set for the FIXTURE ORIGINAL.
• Data Provenance: Not applicable / Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable. No new test set or ground truth determination described for the FIXTURE ORIGINAL.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. No new test set or ground truth determination described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No. This is a submission for an endosseous implant, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Standalone Performance Study: No. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: Not applicable for the FIXTURE ORIGINAL itself in this submission. The "ground truth" for the submission's argument is the established safety and effectiveness of the predicate device based on its existing regulatory clearance.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not a machine learning or AI device.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable.

Summary of the Submission's Approach:

The K021355 submission for the Brånemark Integration AB FIXTURE ORIGINAL relies entirely on demonstrating substantial equivalence to a previously cleared predicate device (Nobel Biocare Standard Fixture, K925765). The argument is built on the following points:

• Identical Intended Use: Both devices share the same intended use for permanent anchorage of prosthetic devices and restoring chewing function.
• Similar Dimensions: The FIXTURE ORIGINAL's dimensions (diameter 3.75mm, length 8.5-15mm) fall within the range of the predicate device (diameter 3.75mm, length 7-20mm).
• Similar Material: Although not explicitly stated as "identical material" in the provided text, the phrase "substantially equivalent to Nobel Biocare Standard Fixture in material, dimensions, and intended use" strongly implies material similarity.
• Previous Testing of Predicate: The submission refers to existing "mechanical testing requested for Screw-type Endosseous Implants as described in the Guideline 'Information Necessary for Pre Market Notification Submission for Screw-Type Endosseous Implants', dated December 9, 1996," completed for the predicate device.

The conclusion drawn by Brånemark Integration AB is that "further testing will not raise new issues of safety and efficacy" because of this substantial equivalence. The FDA concurred with this assessment, granting 510(k) clearance based on this argument, not on new performance data for the FIXTURE ORIGINAL.

Ask a specific question about this device

Endosseous implants and abutments are indicated for surgical placement into the upper and Lower jar arches as permanent support for prosthetic appliances, to restore a patient's masticatory fower jur arches as permaint oupport resally coating applied to implants/abutments improves the overall esthetics of the completed restoration.

3i proposes to apply a TiN coating to abutment cylinder surfaces with exception of the implant mating surface interface area. On implants, the coating will be applied to coronal. transgingival collar area. Implant/abutment interface surfaces will not be coated. Current dimensional characteristics and specifications for implants and abutments to be TiN coated do not change. Cleaning, packaging and sterilization operations will be accomplished by the same means and under the same controls as non-TiN coated implants and abutments.

The provided text is a 510(k) summary for a medical device (TiN Coated Implants and Abutments). It details the device, its intended use, and evaluations for substantial equivalence, but it does not contain a study that proves the device meets specific acceptance criteria in the format of a clinical trial or performance study with defined metrics, sample sizes, and ground truth.

Instead, the document focuses on:

• Biocompatibility: Stating that Titanium Nitride (TiN) is a proven biocompatible material based on existing literature and its widespread use.
• Physical Performance Evaluation: Describing a limited set of physical tests to assess adhesion and performance with cement-retained prosthetics.
• Substantial Equivalence Argument: Asserting that the TiN-coated devices are substantially equivalent to existing 3i implants/abutments and competitive systems already using TiN coatings, primarily differing only in the TiN coating itself.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, experts, and ground truth cannot be extracted directly from this document in the manner typically associated with studies proving device performance against specific, quantifiable acceptance criteria.

However, I can extract the available information regarding the "device performance evaluation" and present it as acceptance criteria for those specific tests.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. The document uses phrases like "TiN abutments" and "copings" without providing the number of units tested for any of the physical performance evaluations.
• Data Provenance: Not specified, but generally, such tests would be conducted by the manufacturer in a laboratory setting. It is not explicitly stated whether the data were retrospective or prospective, but performance evaluations are typically prospective for new device features.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/Not specified. The "ground truth" for the physical performance tests (scratch adhesion, visual observation of delamination, removal force) would be the direct measurements or observations from the tests themselves, not expert consensus on clinical outcomes. For qualitative assessments like "no de-lamination" or "not removed," it would be the judgment of the test operator, whose qualifications are not mentioned.

4. Adjudication method for the test set

• Not applicable/Not specified. For the physical performance tests, the results are objective measurements or direct observations. There's no mention of a panel or group needing to adjudicate conflicting interpretations of test results.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This document does not mention an MRMC study. The device is a physical dental implant coating, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This document does not describe an algorithm or AI component.

7. The type of ground truth used

• For the physical performance evaluation:
  • Scratch Adhesion: Direct measurement of force in kilograms.
  • Adhesion of cemented prosthetics (visual observation): Direct visual observation of the coating integrity.
  • Removal force of cemented prosthetics: Direct measurement of force.
  • Resistance to scraping: Direct visual observation of coating integrity after scraping.
• For the overall device: The "ground truth" for its safety and effectiveness is largely based on its substantial equivalence to legally marketed predicate devices and the established biocompatibility of TiN.

8. The sample size for the training set

• Not applicable. There is no AI/algorithm being trained, so no training set is mentioned or relevant.

9. How the ground truth for the training set was established

• Not applicable. No training set is mentioned.

Ask a specific question about this device